COVID-19: Two New Treatments Approved by EMA

Dawn O'Shea

November 16, 2021

The European Medicines Agency (EMA) has approved two new treatments for COVID-19 - Ronapreve (casirivimab/imdevimab) and Regkirona (regdanvimab).

Ronapreve and Regkirona are the first monoclonal antibody medicines to receive a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) and join the list of COVID-19 products that have received a positive opinion since Veklury (remdesivir) was recommended for authorisation in June 2020.

Ronapreve is indicated for the treatment of COVID-19 in adults and adolescents over 12 years of age and weighing at least 40 kg, who do not require supplemental oxygen and who are at increased risk of progressing to severe disease. The drug can also be used to prevent COVID-19 in the same population.

Regkirona is indicated for the treatment of adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of severe disease.

Studies have shown that Ronapreve or Regkirona significantly reduce hospitalisation and deaths in patients at risk of severe COVID-19. Ronapreve has also been shown to reduce of risk of infection from an infected household member.

The CHMP’s recommendations will now be sent to the European Commission for rapid legally binding decisions.

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